MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This case was reported via regulatory authority (b)(6) (reference number: (b)(4)) on 03-mar-2017.This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("coils broke"), complication of device insertion ("during placement of the intra-tubal device on the left, a problem occured with the introducer, leading to defective release"), device deployment issue ("during placement of the intra-tubal device on the left, a problem occured with the introducer, leading to defective release") and complication of device removal ("it was impossible to separate the introducer, requiring general anaesthesia and use of biopsy forceps") in a female patient who received essure (batch no.623209).The patient's concurrent conditions included general anaesthesia.On (b)(6) 2010, the patient started essure.On (b)(6) 2010, the same day after starting essure, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage, complication of device insertion, device deployment issue and complication of device removal outcome was unknown.The reporter provided no causality assessment for device breakage, complication of device insertion, device deployment issue and complication of device removal with essure.The reporter commented: it was impossible to separate the introducer, requiring general anaesthetic and use of biopsy forceps, which broke the coils, and another instrument to remove the material from the patient.Company causality comment this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during insertion procedure, a device breakage ("coils broke") occurred.During insertion of the left device, it was impossible to separate the introducer.Therefore general anaesthesia was applied and a biopsy forceps was used which led to breakage of the coils.Another instrument was used to remove the material from the patient.Device breakage is non-serious and anticipated in the reference safety information for essure.As device breakage occurred at time of essure insertion procedure and regarding the event's nature, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident due to breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.A product technical analysis and further information has been requested.

Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the ansm, health authority of (b)(4), device vigilance database via legal proceedings.Following receipt, bayer consulted ansm in order to obtain the relevant case reference number information.On march 24, 2017, ansm provided the available corresponding case reference numbers to bayer.Upon receipt of this information bayer evaluated and processed the cluster of essure reports within the global safety database by april 12, 2017.

Manufacturer Narrative

This case was reported via (b)(6) ((b)(4)) on 03-mar-2017.This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("coils broke"), complication of device insertion ("during placement of the intra-tubal device on the left, a problem occured with the introducer, leading to defective release"), device deployment issue ("during placement of the intra-tubal device on the left, a problem occured with the introducer, leading to defective release") and complication of device removal ("it was impossible to separate the introducer, requiring general anaesthesia and use of biopsy forceps") in a female patient who had essure (batch no.623209) inserted.The patient's concurrent conditions included general anaesthesia.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage, complication of device insertion, device deployment issue and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and device deployment issue with essure.The reporter commented: it was impossible to separate the introducer, requiring general anaesthetic and use of biopsy forceps, which broke the coils, and another instrument to remove the material from the patient.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 14-jun-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1639 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Most recent follow-up information incorporated above includes: on 9-jun-2017: no further information was obtained despite follow-up attempts.Company causality comment.Other reportable incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This case was reported via regulatory authority (b)(6) on (b)(6) 2017 with additional information received on 12-oct-2017.This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("coils broke"), complication of device insertion ("during placement of the intra-tubal device on the left, a problem occured with the introducer, leading to defective release"), device deployment issue ("during placement of the intra-tubal device on the left, a problem occured with the introducer, leading to defective release") and complication of device removal ("it was impossible to separate the introducer, requiring general anaesthesia and use of biopsy forceps") in a female patient who had essure (batch no.623209) inserted.The patient's concurrent conditions included general anaesthesia.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage, complication of device insertion, device deployment issue and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and device deployment issue with essure.The reporter commented: it was impossible to separate the introducer, requiring general anaesthetic and use of biopsy forceps, which broke the coils, and another instrument to remove the material from the patient.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 13-oct-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.803 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-oct-2017: quality-safety evaluation, entry of fda codes, expiration date, mfr date: unable to confirm complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd, p.o. box 915; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6534201
• MDR Text Key: 74314456
• Report Number: 2951250-2017-01809
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 623209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1